Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that KRAS p.G12C status confers therapeutic sensitivity to Sotorasib in patients with Non-Small Cell Lung Cancer.

The European Medicines Agency (EMA) has authorized sotorasib as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with the KRAS p.G12C variant and who have progressed after at least one prior line of systemic therapy.

This statement is based on a regulatory approval from the European Medicines Agency:

LUMYKRAS as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.

Citation

Amgen Europe BV. Lumykras (sotorasib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/lumykras-epar-product-information_en.pdf. Revised February 2024. Accessed March 19, 2024.